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MyLabSigma
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 101741004Model 7410Ref 101741007
Identity
- Trade Name
- MyLabSigma EUDAMEDFDA UDIMyLabSigma elite EUDAMEDFDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 7410 EUDAMED101741004 EUDAMEDFDA UDI101741007 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304453679 EUDAMEDFDA UDI08056304454263 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.US0000006.YA EUDAMEDB-08056304454263 EUDAMEDB-08056304453679 EUDAMED
- 510(k) Number
- K191072 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040103 PORTABLE ULTRASOUND SCANNERS EUDAMED
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MyLabSigma by Esaote S.p.A. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805630445ESA.US0000006.YA | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.US0000006.YA | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (6)
- EUDAMED ae4b1a64-bdc1-4ee5-b28b-4f42e4d72132 61 fields · synced Jul 25, 2026
- EUDAMED 7a92ec25-503b-4d3b-8240-396b58d5abcf 61 fields · synced May 17, 2026
- EUDAMED 4f07f77f-c75c-47a6-9f04-3a93266eee56 61 fields · synced May 19, 2026
- FDA UDI 3e078599-0f97-4c02-893b-a9ff19143ae5 33 fields · synced May 30, 2026
- FDA UDI 4fa6c667-6ade-4c4a-a8c9-6c9bc3e1f338 33 fields · synced May 30, 2026
- EUDAMED 4efca162-c38c-4f0f-b7a5-9c66732f6615 61 fields · synced Jul 10, 2026